PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Report

• Report Number: 1020279-2025-01726
• Event Type: Injury
• Date Received: October 17, 2025
• Report Date: April 28, 2026
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: LPH
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: AS
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

CORRECTED DATA: A2 (AGE AT THE TIME OF EVENT CORRECTED FROM 69 TO 71 YEARS), B5 (EVENT NARRATIVE). H11: THE SUBMISSION CONSOLIDATES MULTIPLE INTO A SINGLE DATASET PER FDA¿S RWD2300584 EXEMPTION GUIDANCE. ALL 541 REVISIONS WERE INCLUDED IN PRIOR QUARTERLY SUBMISSIONS FOR THE SAME REGISTRY AND ARE RE-LISTED HERE FOR COMPLETENESS AND ALIGNMENT. NEW INFORMATION IN THIS REPORT IS LIMITED TO UPDATED REGISTRY DATA TIMEFRAMES AND THE RESULTING UPDATED DATA, SUCH AS CUMULATIVE REVISION RATES AND PATIENT AGE. REPORTING QUARTER: 2 (01-APR-2025 TO 30-JUN-2025) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN THAS: 1. PRIMARY TOTAL HIP ARTHROPLASTY (THA): - OR3O DUAL MOBILITY XLPE INSERT: A TOTAL OF TWO HUNDRED AND SEVENTY-SIX (276) HIPS UNDERWENT PRIMARY THA BETWEEN 15-JUL-2021 AND 30-JUN-2025, UPON WHICH AN OR3O HIP INSERT WAS PLACED. FROM THESE, ONE (1) HIP PRESENTED MALPOSITION WHICH REQUIRED REVISION SURGERY. - R3 CONSTRAINED LINER: A TOTAL OF THIRTY-FOUR (34) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 1-SEP-1999 TO 20-MAR-2025, USING AN R3 CONSTRAINED LINER. FROM THESE, TWO (2) HIPS WERE LATER REVISED DUE TO IMPLANT BREAKAGE OF THE ACETABULAR INSERT (X1) AND ASEPTIC LOOSENING (X1). - REFLECTION UHMWPE LINER: A TOTAL OF TWO THOUSAND SIX HUNDRED AND SIXTEEN (2,616) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 02-SEP-1999 AND 30-JUN-2009, USING A REFLECTION ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) LINER. FROM THESE, FOUR HUNDRED AND TWENTY NINE (429) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY-NINE (29) HIPS DUE TO FRACTURE, ONE HUNDRED AND FIFTY (150) HIPS DUE TO LOOSENING, FORTY-TWO (42) HIPS DUE TO INFECTION, SEVENTY (70) HIPS DUE TO PROSTHESIS DISLOCATION, SEVENTY-ONE (71) HIPS DUE TO LYSIS, ONE (1) HIP DUE TO PAIN, TWO (2) HIPS DUE TO INSTABILITY, TWO (2) HIPS DUE TO LEG LENGTH DISCREPANCY, ONE (1) HIP DUE TO MALPOSITION, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, ONE (1) HIP DUE TO INCORRECT SIZING, FIFTY (50) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, THREE (3) HIPS DUE TO WEAR ¿ ACETABULUM, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND TWO (2) HIPS DUE TO OTHER CAUSES. - REFLECTION XLPE ACETABULAR LINER: A TOTAL OF THIRTEEN THOUSAND NINE HUNDRED AND SEVENTY-ONE (13,971) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 05-OCT-2020 AND 28-JAN-2025, USING A REFLECTION XLPE LINER. THIS TOTAL INCLUDES REFLECTION XLPE LINER COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JDI AND LPH. OF THE FIVE HUNDRED AND FIFTY-SEVEN (557) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, ONE HUNDRED THREE (103) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 557 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LPH. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO PERIPROSTHETIC FRACTURE, TWO HUNDRED AND FORTY (240) HIPS DUE TO LOOSENING, ONE HUNDRED AND THIRTY-FOUR (134) HIPS DUE TO INFECTION, ONE HUNDRED AND SIXTY-THREE (163) HIPS DUE TO PROSTHESIS DISLOCATION, SIXTY-EIGHT (68) HIPS DUE TO LYSIS, SEVEN (7) HIPS DUE TO INSTABILITY, FIVE (5) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, FORTY-THREE (43) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND ONE (1) HIP DUE TO WEAR ¿ ACETABULUM. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 557 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 103 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 103 CASES. 2. REVISION TOTAL HIP ARTHROPLASTY (THA): - REFLECTION ACETABULAR SHELL: TOTAL OF NINETY-FIVE (95) HIP JOINTS UNDERWENT REVISION THA PROCEDURES USING A REFLECTION ACETABULAR SHELL IN LIEU OF THE PRIMARY COMPONENT BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES REFLECTION ACETABULAR SHELL COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES LPH, MBL AND MEH. FROM THIS COHORT, EIGHTEEN (18) HIPS UNDERWENT A RE-REVISION SURGERY DUE TO SEVERAL CAUSES. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR ALL 18 RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LPH. THE REPORTED REASONS FOR RE-REVISION INCLUDE: SIX (6) HIPS DUE TO PROTHESIS DISLOCATION, FIVE (5) DUE TO INFECTION, AND THE SEVEN (7) REMAINING JOINTS BECAUSE OF THE FOLLOWING CAUSES (ONE PER JOINT): LOOSENING, FRACTURE, STEM IMPLANT BREAKAGE, LYSIS, PAIN, HETEROTOPIC BONE, AND WEAR OF THE ACETABULAR INSERT. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 18 RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 3 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR SHELL COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR RE-REVISION EXCLUSIVELY TO THE SUBSET OF 3 CASES. - REFLECTION MULTI-HOLE ACETABULAR CUP: A TOTAL OF TWENTY-THREE (23) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 20-APR-2004 AND 7-SEP-2013, USING A REFLECTION MULTI-HOLE ACETABULAR CUP. FROM THESE, THREE (3) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO LOOSENING, ONE (1) HIP DUE TO PROSTHETIC DISLOCATION AND ONE (1) HIP DUE TO OTHER UNKNOWN REASONS. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION OR RE-REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THE PROCEDURES USING A REFLECTION SHELL AND LINER. ALTOGETHER, A TOTAL QUANTITY OF 535 REVISIONS AND 6 RE-REVISIONS (541 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE OR3O DUAL MOBILITY SYSTEM, THE R3 ACETABULAR SYSTEM AND THE REFLECTION ACETABULAR SYSTEM PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL THEIR THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR AUTOMATED INDUSTRY REPORTS FOR THE ABOVE-MENTIONED SMITH+NEPHEW PROSTHESES USED IN PRIMARY AND REVISION THAS WERE REVIEWED. A TOTAL OF TWO HUNDRED AND SEVENTY-SIX (276) PRIMARY THAS WITH OR3O HIP INSERTS WERE PERFORMED IN AUSTRALIA BETWEEN 15-JUL-2021 AND 30-JUN-2025. DUE TO LIMITED FOLLOW-UP DURATION (MAXIMUM OF 4.08 YEARS), ONLY THE ONE-YEAR CUMULATIVE PERCENT REVISION (CPR) IS AVAILABLE FOR THE OR30 GROUP. THE REVISION RATE FOR OR30 DUAL MOBILITY SYSTEM IS IN LINE WITH THE CLASS FOR ALL OTHER CONVENTIONAL THA AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS. DUE TO THE LOW NUMBER OF RECORDED IMPLANTATIONS, THE CONFIDENCE INTERVALS FOR OR3O DUAL MOBILITY SYSTEM REVISION RATE ARE WIDER THAN THE CLASS. A TOTAL OF THIRTY-FOUR (34) PRIMARY THA IMPLANTATIONS WITH THE R3 CONSTRAINED LINER WERE PERFORMED IN AUSTRALIA BETWEEN 1-SEP-1999 TO 20-MAR-2025. ONLY TWO (2) REVISIONS WERE REPORTED: IMPLANT BREAKAGE ACETABULAR INSERT (2.94%) AND LOOSENING (2.94%). THE REVISIONS PER 100 OBSERVATION YEARS WITH 95% CONFIDENCE INTERVALS FOR THE R3 CONSTRAINED LINERS (1.38; 0.17-4.99) WAS HIGHER THAN THE TOTAL CONVENTIONAL THA CLASS (0.65; 0.64-0.66). THIS DIFFERENCE WAS NON-SIGNIFICANT BASED ON OVERLAPPING OF CONFIDENCE INTERVALS. HOWEVER, CONFIDENCE INTERVALS FOR THE R3 CONSTRAINED LINERS WERE WIDE DUE TO THE LOW NUMBER OF IMPLANTATIONS. A TOTAL OF TWO THOUSAND SIX HUNDRED AND SIXTEEN (2,616) HIPS UNDERWENT PRIMARY THA IMPLANTATIONS WITH THE REFLECTION UHMWPE LINER BETWEEN 02-SEP-1999 AND 30-JUN-2009. THE REFLECTION SYSTEM UTILIZING THE UHMWPE LINER DEMONSTRATED STATISTICALLY SIGNIFICANTLY INFERIOR PERFORMANCE COMPARED TO ALL OTHER THA IN THE AOANJRR, BASED ON NON-OVERLAPPING CONFIDENCE INTERVALS AT 3 TO 22 YEARS OF FOLLOW-UP. IT IS IMPORTANT TO NOTE THAT CONVENTIONAL POLYETHYLENE HAS BEEN EXTENSIVELY REPORTED IN THE LITERATURE TO GENERATE INCREASED WEAR DEBRIS OVER TIME, WHICH IS ASSOCIATED WITH HIGHER REVISION RATES. THESE LINERS, WHICH HAVE SHOWN LOWER PERFORMANCE RELATIVE TO XLPE LINERS, ARE NO LONGER COMMERCIALLY AVAILABLE. A TOTAL OF THIRTEEN THOUSAND NINE HUNDRED AND SEVENTY-ONE (13,971) HIPS UNDERWENT PRIMARY THA IMPLANTATIONS WITH THE REFLECTION XLPE ACETABULAR LINER BETWEEN 05-OCT-2020 AND 28-JAN-2025. THE REFLECTION SYSTEM UTILIZING THE XLPE LINER PERFORMED STATISTICALLY SIGNIFICANTLY BETTER AT 23 YEARS (6.3% CI: 5.6, 7.1), BASED ON NON-OVERLAPPING CONFIDENCE INTERVALS WHEN COMPARED TO ALL OTHER THA REPORTED IN THE AOANJRR (11.0% CI: 10.8, 11.3). A TOTAL OF NINETY-FIVE (95) HIP JOINTS UNDERWENT REVISION THA IMPLANTATIONS WITH THE REFLECTION ACETABULAR SHELL BETWEEN 23-OCT-2000 AND 24-JUL-2015. THE MEAN CUMULATIVE RE-REVISION RATES FOR THE REFLECTION ACETABULAR SHELL WERE SIMILAR TO THE CLASS DURING THE FIRST SIXTEEN (16) YEARS BASED ON OVERLAPPING 95% CONFIDENCE INTERVALS. FROM THIS YEAR ONWARD, NO DATA WAS COLLECTED FOR THE REFLECTION ACETABULAR SHELL. THE HAZARD RATIO FOR THE REFLECTION ACETABULAR SHELL VS. THE CLASS OVER THE ENTIRE PERIOD IS 1.00 (95% CI: 0.63¿1.59) WITH A P-VALUE OF 0.985. THIS INDICATES NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE RISK OF SECOND REVISION BETWEEN THE REFLECTION ACETABULAR SHELL AND OTHER MODELS WHEN ADJUSTED FOR AGE AND GENDER. A TOTAL OF TWENTY-THREE (23) REVISION THA IMPLANTATIONS WITH THE REFLECTION MULTI-HOLE ACETABULAR CUP WERE PERFORMED BETWEEN 20-APR-2004 AND 7-SEP-2013. THE CUMULATIVE RE-REVISION RATES FOR THE REFLECTION MULTI-HOLE CUPS WERE IN LINE WITH THE AOANJRR REVISION THA CLASS ACROSS ALL AVAILABLE FOLLOW UP YEARS. REFLECTION MULTI-HOLE CUPS CUMULATIVE RE-REVISION INCIDENCE RATES SHOWED LARGE CONFIDENCE INTERVALS, AT LEAST IN PART DUE TO THE LOW NUMBER OF IMPLANTATIONS FOLLOWED-UP. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Additional Manufacturer Narrative · 0

REPORTING QUARTER 2 (01-APR-2025 TO 30-JUN-2025) SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AOANJRR, SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN THAS. 1. PRIMARY PROCEDURES OR3O DUAL MOBILITY XLPE INSERT: A TOTAL OF A HUNDRED AND NINETY-FIVE (195) HIPS UNDERWENT PRIMARY THA BETWEEN 15-JUL-2021 AND 25-MAR-2025, UPON WHICH AN OR3O HIP INSERT WAS PLACED. FROM THESE, ONE (1) HIP WAS LATER REVISED DUE TO MALPOSITION. R3 CONSTRAINED LINER: A TOTAL OF THIRTY-FOUR (34) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 1-SEP-1999 TO 20-MAR-2025, USING AN R3 CONSTRAINED LINER. FROM THESE, TWO (2) HIPS WERE LATER REVISED DUE TO IMPLANT BREAKAGE OF THE ACETABULAR INSERT (X1) AND ASEPTIC LOOSENING (X1). REFLECTION UHMWPE LINER: A TOTAL OF TWO THOUSAND SIX HUNDRED AND SIXTEEN (2616) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 02-SEP-1999 AND 30-JUN-2009, USING A REFLECTION ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) LINER. FROM THESE, FOUR HUNDRED AND TWENTY NINE (429) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY-NINE (29) HIPS DUE TO FRACTURE, ONE HUNDRED AND FIFTY (150) HIPS DUE TO LOOSENING, FORTY-TWO (42) HIPS DUE TO INFECTION, SEVENTY (70) HIPS DUE TO PROSTHESIS DISLOCATION, SEVENTY-ONE (71) HIPS DUE TO LYSIS, ONE (1) HIP DUE TO PAIN, TWO (2) HIPS DUE TO INSTABILITY, TWO (2) HIPS DUE TO LEG LENGTH DISCREPANCY, ONE (1) HIP DUE TO MALPOSITION, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, ONE (1) HIP DUE TO INCORRECT SIZING, FIFTY (50) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, THREE (3) HIPS DUE TO WEAR ¿ ACETABULUM, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND TWO (2) HIPS DUE TO OTHER CAUSES. REFLECTION XLPE ACETABULAR LINER: A TOTAL OF THIRTEEN THOUSAND NINE HUNDRED AND SEVENTY-ONE (13,971) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 05-OCT-2020 AND 28-JAN-2025, USING A REFLECTION XLPE LINER. THIS TOTAL INCLUDES REFLECTION XLPE LINER COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JDI AND LPH. OF THE FIVE HUNDRED AND FIFTY-SEVEN (557) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, ONE HUNDRED THREE (103) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 557 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LPH. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO PERIPROSTHETIC FRACTURE, TWO HUNDRED AND FORTY (240) HIPS DUE TO LOOSENING, ONE HUNDRED AND THIRTY-FOUR (134) HIPS DUE TO INFECTION, ONE HUNDRED AND SIXTY-THREE (163) HIPS DUE TO PROSTHESIS DISLOCATION, SIXTY-EIGHT (68) HIPS DUE TO LYSIS, SEVEN (7) HIPS DUE TO INSTABILITY, FIVE (5) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, FORTY-THREE (43) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND ONE (1) HIP DUE TO WEAR ¿ ACETABULUM. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 557 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 103 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 103 CASES. 2. REVISION PROCEDURES REFLECTION ACETABULAR SHELL: TOTAL OF NINETY-FIVE (95) HIP JOINTS UNDERWENT REVISION THA PROCEDURES USING A REFLECTION ACETABULAR SHELL IN LIEU OF THE PRIMARY COMPONENT BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES REFLECTION ACETABULAR SHELL COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES LPH, MBL AND MEH. FROM THIS COHORT, EIGHTEEN (18) HIPS UNDERWENT A RE-REVISION SURGERY DUE TO SEVERAL CAUSES. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR ALL 18 RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LPH. THE REPORTED REASONS FOR RE-REVISION INCLUDE: SIX (6) HIPS DUE TO PROTHESIS DISLOCATION, FIVE (5) DUE TO INFECTION, AND THE SEVEN (7) REMAINING JOINTS BECAUSE OF THE FOLLOWING CAUSES (ONE PER JOINT): LOOSENING, FRACTURE, STEM IMPLANT BREAKAGE, LYSIS, PAIN, HETEROTOPIC BONE, AND WEAR OF THE ACETABULAR INSERT. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 18 RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 3 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR SHELL COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR RE-REVISION EXCLUSIVELY TO THE SUBSET OF 3 CASES. REFLECTION MULTI-HOLE ACETABULAR CUP: A TOTAL OF TWENTY-THREE (23) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 20-APR-2004 AND 7-SEP-2013, USING A REFLECTION MULTI-HOLE ACETABULAR CUP. FROM THESE, THREE (3) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO LOOSENING, ONE (1) HIP DUE TO PROSTHETIC DISLOCATION AND ONE (1) HIP DUE TO OTHER UNKNOWN REASONS. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION OR RE-REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THESE PROCEDURES. ALTOGETHER, A TOTAL QUANTITY OF 535 REVISIONS AND 6 RE-REVISIONS (541 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AOANJRR FOLLOWING THE USE OF THE S+N IMPLANTS REFERENCED ABOVE. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE OR3O DUAL MOBILITY SYSTEM, THE R3 ACETABULAR SYSTEM AND THE REFLECTION ACETABULAR SYSTEM PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL THEIR THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AOANJRR AUTOMATED INDUSTRY REPORTS FOR THE ABOVE-MENTIONED SMITH+NEPHEW PROSTHESES USED IN PRIMARY AND REVISION THAS WERE REVIEWED. A TOTAL OF A HUNDRED AND NINETY-FIVE (195) PRIMARY THA IMPLANTATIONS WITH THE OR3O DUAL MOBILITY XLPE INSERT WERE PERFORMED IN AUSTRALIA BETWEEN 15-JUL-2021 AND 25-MAR-2025. DUE TO LIMITED FOLLOW-UP DURATION (MAXIMUM OF 3.84 YEARS), ONLY THE ONE-YEAR CUMULATIVE PERCENT REVISION (CPR) IS AVAILABLE FOR THE OR30 GROUP. THE REVISION RATE FOR OR30 DUAL MOBILITY SYSTEM IS IN LINE WITH THE CLASS FOR ALL OTHER CONVENTIONAL THA AS SHOWN BY OVERLAPPING CONFIDENCE INTERVALS. DUE TO THE LOW NUMBER OF RECORDED IMPLANTATIONS, THE CONFIDENCE INTERVALS FOR OR3O DUAL MOBILITY SYSTEM REVISION RATE ARE WIDER THAN THE CLASS. A TOTAL OF THIRTY-FOUR (34) PRIMARY THA IMPLANTATIONS WITH THE R3 CONSTRAINED LINER WERE PERFORMED IN AUSTRALIA BETWEEN 1-SEP-1999 TO 20-MAR-2025. ONLY TWO (2) REVISIONS WERE REPORTED: IMPLANT BREAKAGE ACETABULAR INSERT (2.94%) AND LOOSENING (2.94%). THE REVISIONS PER 100 OBSERVATION YEARS WITH 95% CONFIDENCE INTERVALS FOR THE R3 CONSTRAINED LINERS (1.38; 0.17-4.99) WAS HIGHER THAN THE TOTAL CONVENTIONAL THA CLASS (0.65; 0.64-0.66). THIS DIFFERENCE WAS NON-SIGNIFICANT BASED ON OVERLAPPING OF CONFIDENCE INTERVALS. HOWEVER, CONFIDENCE INTERVALS FOR THE R3 CONSTRAINED LINERS WERE WIDE DUE TO THE LOW NUMBER OF IMPLANTATIONS. A TOTAL OF TWO THOUSAND SIX HUNDRED AND SIXTEEN (2,616) HIPS UNDERWENT PRIMARY THA IMPLANTATIONS WITH THE REFLECTION UHMWPE LINER BETWEEN 02-SEP-1999 AND 30-JUN-2009. THE REFLECTION SYSTEM UTILIZING THE UHMWPE LINER DEMONSTRATED STATISTICALLY SIGNIFICANTLY INFERIOR PERFORMANCE COMPARED TO ALL OTHER THA IN THE AOANJRR, BASED ON NON-OVERLAPPING CONFIDENCE INTERVALS AT 3 TO 22 YEARS OF FOLLOW-UP. IT IS IMPORTANT TO NOTE THAT CONVENTIONAL POLYETHYLENE HAS BEEN EXTENSIVELY REPORTED IN THE LITERATURE TO GENERATE INCREASED WEAR DEBRIS OVER TIME, WHICH IS ASSOCIATED WITH HIGHER REVISION RATES. THESE LINERS, WHICH HAVE SHOWN LOWER PERFORMANCE RELATIVE TO XLPE LINERS, ARE NO LONGER COMMERCIALLY AVAILABLE. A TOTAL OF THIRTEEN THOUSAND NINE HUNDRED AND SEVENTY-ONE (13,971) HIPS UNDERWENT PRIMARY THA IMPLANTATIONS WITH THE REFLECTION XLPE ACETABULAR LINER BETWEEN 05-OCT-2020 AND 28-JAN-2025. THE REFLECTION SYSTEM UTILIZING THE XLPE LINER PERFORMED STATISTICALLY SIGNIFICANTLY BETTER AT 23 YEARS (6.3% CI: 5.6, 7.1), BASED ON NON-OVERLAPPING CONFIDENCE INTERVALS WHEN COMPARED TO ALL OTHER THA REPORTED IN THE AOANJRR (11.0% CI: 10.8, 11.3). A TOTAL OF NINETY-FIVE (95) HIP JOINTS UNDERWENT REVISION THA IMPLANTATIONS WITH THE REFLECTION ACETABULAR SHELL BETWEEN 23-OCT-2000 AND 24-JUL-2015. THE MEAN CUMULATIVE RE-REVISION RATES FOR THE REFLECTION ACETABULAR SHELL WERE SIMILAR TO THE CLASS DURING THE FIRST SIXTEEN (16) YEARS BASED ON OVERLAPPING 95% CONFIDENCE INTERVALS. FROM THIS YEAR ONWARD, NO DATA WAS COLLECTED FOR THE REFLECTION ACETABULAR SHELL. THE HAZARD RATIO FOR THE REFLECTION ACETABULAR SHELL VS. THE CLASS OVER THE ENTIRE PERIOD IS 1.00 (95% CI: 0.63¿1.59) WITH A P-VALUE OF 0.985. THIS INDICATES NO STATISTICALLY SIGNIFICANT DIFFERENCE IN THE RISK OF SECOND REVISION BETWEEN THE REFLECTION ACETABULAR SHELL AND OTHER MODELS WHEN ADJUSTED FOR AGE AND GENDER. A TOTAL OF TWENTY-THREE (23) REVISION THA IMPLANTATIONS WITH THE REFLECTION MULTI-HOLE ACETABULAR CUP WERE PERFORMED BETWEEN 20-APR-2004 AND 7-SEP-2013. THE CUMULATIVE RE-REVISION RATES FOR THE REFLECTION MULTI-HOLE CUPS WERE IN LINE WITH THE AOANJRR REVISION THA CLASS ACROSS ALL AVAILABLE FOLLOW UP YEARS. REFLECTION MULTI-HOLE CUPS CUMULATIVE RE-REVISION INCIDENCE RATES SHOWED LARGE CONFIDENCE INTERVALS, AT LEAST IN PART DUE TO THE LOW NUMBER OF IMPLANTATIONS FOLLOWED-UP. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem · 0

2025-00279133-1-L7,,4/28/2026,3/11/2026,OR3O DUAL MOBILITY,OR30 DUAL MOBILITY XLPE INSERT 28/38,71358215,,71358215,,00885556724897,K220959,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) a total of five hundred and twenty-one (521) hips underwent primary THR between 15-Jul-2021 and 21-Jan-2026, upon which an OR3O XLPE Dual Mobility Insert was placed. Of these, one (1) hip required revision surgery due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five hundred and twenty-one (521) hips underwent primary THR between 15-Jul-2021 and 21-Jan-2026 in which a OR3O XLPE Dual Mobility Liner was implanted. Of these, ten (10) hips required revision due to the following reasons: four (4) hips due to infection, two (2) due to prosthesis dislocation, two (2) due to fracture, one (1) due to malposition, and one (1) due to instability.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 15-Jul-2021 and 21-Jan-2026 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of five hundred and twenty-one (521) hips underwent primary THR in which a OR3O XLPE Dual Mobility Liner was implanted in Australia between 15-Jul-2021 and 21-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st post-operative year: 2.0% (1.1%¿3.7%) vs 1.8% (1.7%¿1.8%) of the class. ; - At 2nd post-operative year: 2.0% (1.1%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;;During the two years of follow-up, the revision rates of the OR3O XLPE Dual Mobility Liner were in line with the THR class, as determined by overlapping 95% confidence intervals throughout this period. Due to the low number of recorded implantations, the confidence intervals for OR3O Dual Mobility System revision rate are wider than the class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279133-1-L8,,4/28/2026,3/11/2026,OR3O DUAL MOBILITY,OR30 DUAL MOBILITY XLPE INSERT 28/38,71358215,,71358215,,00885556724897,K220959,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) a total of five hundred and twenty-one (521) hips underwent primary THR between 15-Jul-2021 and 21-Jan-2026, upon which an OR3O XLPE Dual Mobility Insert was placed. Of these, one (1) hip required revision surgery due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five hundred and twenty-one (521) hips underwent primary THR between 15-Jul-2021 and 21-Jan-2026 in which a OR3O XLPE Dual Mobility Liner was implanted. Of these, ten (10) hips required revision due to the following reasons: four (4) hips due to infection, two (2) due to prosthesis dislocation, two (2) due to fracture, one (1) due to malposition, and one (1) due to instability.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 15-Jul-2021 and 21-Jan-2026 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of five hundred and twenty-one (521) hips underwent primary THR in which a OR3O XLPE Dual Mobility Liner was implanted in Australia between 15-Jul-2021 and 21-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st post-operative year: 2.0% (1.1%¿3.7%) vs 1.8% (1.7%¿1.8%) of the class. ; - At 2nd post-operative year: 2.0% (1.1%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;;During the two years of follow-up, the revision rates of the OR3O XLPE Dual Mobility Liner were in line with the THR class, as determined by overlapping 95% confidence intervals throughout this period. Due to the low number of recorded implantations, the confidence intervals for OR3O Dual Mobility System revision rate are wider than the class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279133-1-L9,,4/28/2026,3/11/2026,OR3O DUAL MOBILITY,OR30 DUAL MOBILITY XLPE INSERT 28/40,71358217,,71358217,,00885556712368,K220959,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) a total of five hundred and twenty-one (521) hips underwent primary THR between 15-Jul-2021 and 21-Jan-2026, upon which an OR3O XLPE Dual Mobility Insert was placed. Of these, one (1) hip required revision surgery due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five hundred and twenty-one (521) hips underwent primary THR between 15-Jul-2021 and 21-Jan-2026 in which a OR3O XLPE Dual Mobility Liner was implanted. Of these, ten (10) hips required revision due to the following reasons: four (4) hips due to infection, two (2) due to prosthesis dislocation, two (2) due to fracture, one (1) due to malposition, and one (1) due to instability.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 15-Jul-2021 and 21-Jan-2026 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of five hundred and twenty-one (521) hips underwent primary THR in which a OR3O XLPE Dual Mobility Liner was implanted in Australia between 15-Jul-2021 and 21-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st post-operative year: 2.0% (1.1%¿3.7%) vs 1.8% (1.7%¿1.8%) of the class. ; - At 2nd post-operative year: 2.0% (1.1%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;;During the two years of follow-up, the revision rates of the OR3O XLPE Dual Mobility Liner were in line with the THR class, as determined by overlapping 95% confidence intervals throughout this period. Due to the low number of recorded implantations, the confidence intervals for OR3O Dual Mobility System revision rate are wider than the class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00279133-1-L10,,4/28/2026,3/11/2026,OR3O DUAL MOBILITY,OR30 DUAL MOBILITY XLPE INSERT 28/40,71358217,,71358217,,00885556712368,K220959,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR) a total of five hundred and twenty-one (521) hips underwent primary THR between 15-Jul-2021 and 21-Jan-2026, upon which an OR3O XLPE Dual Mobility Insert was placed. Of these, one (1) hip required revision surgery due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of five hundred and twenty-one (521) hips underwent primary THR between 15-Jul-2021 and 21-Jan-2026 in which a OR3O XLPE Dual Mobility Liner was implanted. Of these, ten (10) hips required revision due to the following reasons: four (4) hips due to infection, two (2) due to prosthesis dislocation, two (2) due to fracture, one (1) due to malposition, and one (1) due to instability.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 15-Jul-2021 and 21-Jan-2026 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the OR3O Dual Mobility System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of five hundred and twenty-one (521) hips underwent primary THR in which a OR3O XLPE Dual Mobility Liner was implanted in Australia between 15-Jul-2021 and 21-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; - At 1st post-operative year: 2.0% (1.1%¿3.7%) vs 1.8% (1.7%¿1.8%) of the class. ; - At 2nd post-operative year: 2.0% (1.1%¿3.7%) vs 2.2% (2.2%¿2.2%) of the class;;During the two years of follow-up, the revision rates of the OR3O XLPE Dual Mobility Liner were in line with the THR class, as determined by overlapping 95% confidence intervals throughout this period. Due to the low number of recorded implantations, the confidence intervals for OR3O Dual Mobility System revision rate are wider than the class.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L2,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L3,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L4,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L5,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L6,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L7,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L8,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L9,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L10,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L11,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L12,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L13,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L14,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L15,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L16,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L17,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L18,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L19,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L20,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L21,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L22,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 4,71302204,,71302204,,03596010194046,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L23,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 4,71302204,,71302204,,03596010194046,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L24,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 4,71302204,,71302204,,03596010194046,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L25,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 8,71302208,,71302208,,03596010194053,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L26,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L27,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L28,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L29,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L30,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L31,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L32,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L33,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L34,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L35,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L36,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L37,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L38,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L39,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L40,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L41,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L42,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L43,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L44,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L45,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L46,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L47,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L48,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L49,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L50,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L51,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 0,71302600,,71302600,,03596010194077,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L52,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L53,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L54,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L55,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L56,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L57,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L58,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L59,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L60,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L61,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 4,71302604,,71302604,,03596010194084,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L62,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 8,71302608,,71302608,,03596010194091,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L63,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 8,71302608,,71302608,,03596010194091,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L64,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 8,71302608,,71302608,,03596010194091,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L65,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 8,71302608,,71302608,,03596010194091,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L66,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 8,71302608,,71302608,,03596010194091,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L67,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 8,71302608,,71302608,,03596010194091,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L68,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 26MM + 12,71302612,,71302612,,03596010194107,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L69,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L70,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L71,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L72,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L73,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L74,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L75,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L76,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L77,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L78,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L79,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L80,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L81,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L82,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L83,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L84,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L85,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L86,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L87,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L88,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L89,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L90,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L91,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L92,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L93,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L94,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L95,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L96,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L97,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L98,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L99,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L100,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L101,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L102,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L103,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L104,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L105,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L106,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L107,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L108,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L109,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L110,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L111,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L112,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L113,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L114,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L115,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L116,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L117,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L118,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L119,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L120,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L121,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L122,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L123,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L124,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L125,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L126,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L127,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L128,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L129,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L130,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L131,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L132,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L133,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L134,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L135,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L136,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L137,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L138,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L139,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L140,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L141,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L142,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L143,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L144,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L145,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L146,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L147,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L148,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L149,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L150,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L151,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L152,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L153,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L154,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L155,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L156,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L157,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L158,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L159,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L160,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L161,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L162,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L163,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L164,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L165,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L166,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L167,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L168,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L169,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L170,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L171,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L172,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L173,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L174,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L175,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L176,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L177,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L178,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L179,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L180,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L181,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L182,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L183,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L184,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L185,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L186,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L187,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L188,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L189,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L190,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L191,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L192,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L193,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L194,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L195,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L196,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L197,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L198,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L199,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L200,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L201,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L202,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L203,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L204,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L205,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L206,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L207,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L208,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L209,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L210,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L211,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L212,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L213,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L214,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L215,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L216,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L217,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L218,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L219,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L220,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L221,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L222,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L223,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L224,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L225,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L226,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L227,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L228,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L229,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L230,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L231,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L232,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L233,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L234,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L235,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L236,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L237,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L238,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L239,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L240,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L241,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L242,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L243,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L244,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L245,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L246,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L247,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L248,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L249,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L250,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L251,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L252,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L253,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L254,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L255,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L256,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L257,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L258,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L259,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L260,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L261,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L262,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L263,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L264,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L265,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L266,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L267,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L268,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L269,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L270,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L271,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L272,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L273,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L274,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L275,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L276,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L277,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L278,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L279,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L280,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L281,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L282,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L283,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L284,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L285,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L286,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L287,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L288,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L289,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L290,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L291,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L292,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L293,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L294,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L295,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L296,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L297,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L298,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L299,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L300,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L301,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L302,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L303,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L304,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L305,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L306,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L307,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L308,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L309,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L310,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L311,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L312,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L313,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L314,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L315,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L316,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L317,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L318,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L319,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L320,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L321,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L322,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L323,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L324,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L325,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L326,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L327,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L328,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L329,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L330,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L331,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L332,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L333,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L334,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L335,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L336,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L337,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L338,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L339,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L340,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L341,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L342,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L343,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L344,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L345,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L346,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L347,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L348,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L349,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L350,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L351,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L352,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L353,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L354,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L355,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L356,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L357,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L358,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L359,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L360,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L361,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L362,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L363,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L364,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L365,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L366,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L367,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L368,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L369,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L370,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L371,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L372,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L373,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L374,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L375,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L376,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L377,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L378,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L379,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L380,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L381,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L382,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L383,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L384,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L385,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L386,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L387,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L388,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L389,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L390,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L391,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L392,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L393,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L394,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L395,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L396,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L397,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L398,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L399,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L400,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L401,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L402,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L403,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L404,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L405,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L406,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L407,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L408,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L409,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L410,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L411,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L412,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L413,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L414,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L415,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L416,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L417,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L418,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L419,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L420,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L421,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L422,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L423,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L424,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L425,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L426,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L427,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L428,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L429,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L430,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L431,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L432,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L433,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L434,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L435,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L436,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L437,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L438,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L439,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L440,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L441,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L442,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L443,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L444,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L445,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L446,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L447,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L448,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L449,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L450,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L451,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L452,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L453,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L454,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L455,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L456,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L457,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L458,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L459,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L460,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L461,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L462,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L463,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L464,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L465,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L466,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L467,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L468,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L469,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L470,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L471,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L472,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L473,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L474,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L475,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L476,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L477,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L478,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L479,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L480,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L481,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L482,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L483,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L484,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L485,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L486,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L487,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L488,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L489,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L490,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L491,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L492,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L493,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L494,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L495,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L496,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L497,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L498,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L499,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L500,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L501,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L502,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L503,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L504,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L505,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L506,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L507,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L508,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L509,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L510,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L511,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L512,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L513,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L514,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L515,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L516,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L517,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L518,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L519,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L520,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L521,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L522,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L523,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L524,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L525,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L526,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L527,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L528,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L529,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L530,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L531,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L532,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L533,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L534,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L535,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L536,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L537,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L538,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L539,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L540,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L541,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L542,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L543,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L544,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L545,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L546,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L547,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L548,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L549,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L550,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L551,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L552,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L553,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L554,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L555,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L556,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L557,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L558,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L559,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L560,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L561,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L562,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L563,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L564,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L565,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L566,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L567,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L568,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L569,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L570,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L571,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L572,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L573,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L574,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L575,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L576,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L577,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L578,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L579,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L580,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L581,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L582,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L583,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L584,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L585,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L586,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L587,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L588,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L589,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L590,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L591,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L592,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L593,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L594,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L595,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L596,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 12,71302812,,71302812,,03596010194152,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L597,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L598,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L599,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L600,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L601,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L602,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L603,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L604,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L605,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L606,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L607,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L608,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L609,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L610,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L611,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L612,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L613,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L614,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L615,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L616,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L617,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L618,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L619,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L620,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L621,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L622,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L623,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L624,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L625,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L626,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L627,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L628,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L629,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L630,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L631,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L632,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L633,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L634,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L635,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L636,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L637,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L638,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L639,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L640,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L641,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L642,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L643,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L644,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L645,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L646,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L647,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L648,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L649,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L650,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L651,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L652,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L653,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L654,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L655,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L656,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L657,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L658,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L659,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L660,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L661,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L662,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L663,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L664,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L665,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L666,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L667,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L668,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L669,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L670,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L671,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L672,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L673,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L674,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L675,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L676,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L677,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L678,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L679,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L680,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L681,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L682,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L683,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L684,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L685,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L686,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L687,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L688,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L689,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L690,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L691,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L692,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L693,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L694,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L695,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L696,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L697,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L698,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L699,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L700,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L701,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L702,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L703,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L704,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L705,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L706,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L707,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L708,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L709,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L710,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L711,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L712,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L713,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L714,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L715,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L716,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L717,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L718,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L719,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L720,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L721,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L722,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L723,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L724,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L725,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L726,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L727,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L728,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L729,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L730,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L731,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L732,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L733,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L734,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L735,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L736,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L737,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L738,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L739,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L740,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L741,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L742,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L743,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L744,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L745,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L746,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L747,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L748,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L749,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L750,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L751,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L752,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 0,71303200,,71303200,,03596010194176,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L753,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L754,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L755,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L756,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L757,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L758,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L759,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L760,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L761,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L762,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L763,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L764,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L765,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L766,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L767,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L768,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L769,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L770,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L771,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L772,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L773,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L774,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L775,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L776,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L777,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L778,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L779,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L780,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L781,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L782,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L783,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L784,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L785,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L786,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L787,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L788,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM - 3,71303203,,71303203,,03596010194183,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L789,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L790,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L791,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L792,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L793,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L794,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L795,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L796,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L797,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L798,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L799,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L800,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L801,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L802,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L803,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L804,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L805,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L806,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L807,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L808,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L809,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L810,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L811,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L812,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L813,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L814,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L815,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L816,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L817,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L818,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L819,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L820,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L821,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L822,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L823,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L824,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L825,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L826,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L827,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L828,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L829,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L830,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L831,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L832,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L833,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L834,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L835,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L836,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L837,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L838,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L839,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L840,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L841,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L842,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L843,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L844,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L845,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L846,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L847,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L848,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L849,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L850,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L851,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L852,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L853,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L854,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L855,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L856,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L857,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L858,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L859,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L860,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L861,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L862,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L863,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L864,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L865,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L866,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L867,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L868,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L869,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L870,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L871,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L872,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L873,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L874,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L875,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L876,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L877,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L878,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L879,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L880,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L881,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L882,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L883,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 4,71303204,,71303204,,03596010194190,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L884,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L885,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L886,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L887,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L888,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L889,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L890,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L891,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L892,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L893,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L894,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L895,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L896,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L897,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L898,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L899,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L900,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L901,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L902,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L903,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L904,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L905,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L906,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L907,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L908,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L909,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L910,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L911,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L912,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L913,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L914,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L915,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L916,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L917,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L918,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L919,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L920,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L921,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L922,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L923,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L924,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L925,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L926,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L927,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 8,71303208,,71303208,,03596010194206,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L928,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 12,71303212,,71303212,,03596010194213,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L929,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 12,71303212,,71303212,,03596010194213,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L930,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 32MM + 12,71303212,,71303212,,03596010194213,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L931,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L932,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L933,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L934,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L935,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L936,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L937,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L938,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L939,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L940,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L941,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L942,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L943,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L944,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L945,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L946,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L947,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L948,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L949,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L950,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L951,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L952,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L953,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L954,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L955,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L956,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L957,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L958,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L959,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L960,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L961,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L962,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L963,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L964,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L965,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L966,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L967,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L968,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L969,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L970,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L971,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L972,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L973,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L974,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L975,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L976,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L977,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L978,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L979,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L980,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L981,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L982,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L983,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L984,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L985,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L986,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L987,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L988,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L989,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L990,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L991,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L992,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L993,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L994,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L995,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L996,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L997,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L998,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L999,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1000,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1001,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1002,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1003,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1004,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1005,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1006,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1007,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1008,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1009,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1010,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1011,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1012,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1013,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1014,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1015,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1016,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1017,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1018,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1019,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1020,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1021,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1022,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1023,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1024,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1025,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1026,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1027,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1028,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1029,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1030,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1031,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1032,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1033,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1034,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1035,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1036,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1037,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1038,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1039,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1040,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1041,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1042,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1043,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1044,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1045,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1046,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1047,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1048,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1049,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1050,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1051,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1052,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1053,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1054,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1055,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1056,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1057,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1058,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1059,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1060,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1061,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1062,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1063,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1064,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1065,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1066,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1067,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1068,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1069,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1070,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1071,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1072,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1073,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1074,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1075,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1076,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1077,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1078,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1079,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1080,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +0,71303600,,71303600,,03596010479983,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1081,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1082,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1083,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1084,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1085,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1086,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1087,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1088,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1089,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1090,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1091,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1092,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1093,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1094,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1095,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1096,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1097,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1098,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1099,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1100,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1101,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1102,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1103,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1104,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1105,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1106,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1107,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1108,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1109,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1110,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1111,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1112,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1113,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1114,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1115,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1116,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1117,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1118,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1119,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM -3,71303603,,71303603,,03596010479976,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1120,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1121,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1122,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1123,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1124,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1125,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1126,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1127,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1128,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1129,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1130,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1131,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1132,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1133,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1134,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1135,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1136,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1137,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1138,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1139,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1140,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1141,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1142,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1143,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1144,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1145,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1146,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1147,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1148,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1149,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1150,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1151,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1152,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1153,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1154,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1155,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1156,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1157,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1158,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1159,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1160,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1161,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1162,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1163,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1164,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1165,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1166,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1167,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1168,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1169,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1170,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1171,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1172,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1173,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1174,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1175,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1176,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1177,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1178,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1179,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1180,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1181,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1182,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1183,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1184,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1185,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1186,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1187,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1188,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1189,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1190,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1191,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1192,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1193,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1194,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1195,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1196,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1197,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1198,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1199,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1200,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1201,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +4,71303604,,71303604,,03596010479990,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1202,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1203,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1204,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1205,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1206,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1207,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1208,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1209,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1210,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1211,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1212,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1213,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1214,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1215,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1216,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1217,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1218,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1219,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1220,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1221,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1222,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1223,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1224,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1225,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1226,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1227,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1228,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1229,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1230,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1231,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1232,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1233,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1234,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1235,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1236,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +8,71303608,,71303608,,03596010480002,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1237,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1238,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1239,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1240,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1241,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1242,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1243,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1244,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310311-1-L1245,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 36MM +12,71303612,,71303612,,03596010480019,K022902,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of twenty-three thousand two hundred twenty-six (23,226) hips underwent primary THA procedures between 8-Sep-1999 and 29-Nov-2025, using CoCr Femoral Heads. From these, one thousand two hundred forty-five (1,245) hips were later revised due to the following complications: two hundred and twenty-two (222) hips due to fracture, three hundred and fifty-nine (359) hips due to loosening, two hundred and fifty-six (256) hips due to infection, two hundred and fifty (250) hips due to prosthesis dislocation, fifty-four (54) hips due to lysis, eleven (11) hips due to pain, ten (10) hips due to instability, nine (9) hips due to leg length discrepancy, six (6) hips due to malposition, ten (10) hips due to implant breakage ¿ stem, nine (9) hips due to metal related pathology, twenty-four (24) hips due to wear ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular insert, three (3) hips due to implant breakage ¿ acetabular, three (3) hips due to incorrect sizing, four (4) hips due to tumour, three (3) hips due to wear ¿ acetabulum, and nine (9) hips due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 8-Sep-1999 and 29-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of twenty?three thousand two hundred twenty-six (23,226) procedures with CoCr Femoral Heads have been performed in Australia between 8-Sep-1999 and 29-Nov-2025. ;;The cumulative revision rates for the CoCr Femoral Head demonstrated significantly higher cumulative revision rate than the class device at 10 years based on the non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.9% (1.7%¿2.1%) vs 1.7% (1.7%¿1.8%) of the class.;-At 2nd postoperative year: 2.4% (2.2%¿2.6%) vs 2.2% (2.2%¿2.2%) of the class.;-At 3rd postoperative year: 2.7% (2.5%¿3.0%) vs 2.5% (2.5%¿2.6%) of the class.;-At 4th postoperative year: 3.0% (2.8%¿3.3%) vs 2.8% (2.8%¿2.9%) of the class.;-At 5th postoperative year: 3.4% (3.2%¿3.7%) vs 3.1% (3.1%¿3.2%) of the class.;-At 6th postoperative year: 3.8% (3.5%¿4.1%) vs 3.4% (3.4%¿3.5%) of the class.;-At 7th postoperative year: 4.2% (3.9%¿4.5%) vs 3.7% (3.7%¿3.8%) of the class.;-At 8th postoperative year: 4.6% (4.3%¿4.9%) vs 4.0% (4.0%¿4.1%) of the class.;-At 9th postoperative year: 5.0% (4.7%¿5.3%) vs 4.4% (4.3%¿4.4%) of the class.;-At 10th postoperative year: 5.4% (5.1%¿5.8%) vs 4.7% (4.6%¿4.7%) of the class.;-At 11th postoperative year: 5.9% (5.5%¿6.3%) vs 5.1% (5.0%¿5.1%) of the class.;-At 12th postoperative year: 6.6% (6.2%¿7.0%) vs 5.5% (5.4%¿5.5%) of the class.;-At 13th postoperative year: 7.0% (6.6%¿7.5%) vs 5.9% (5.8%¿5.9%) of the class.;-At 14th postoperative year: 7.7% (7.2%¿8.2%) vs 6.3% (6.2%¿6.4%) of the class.;-At 15th postoperative year: 8.1% (7.6%¿8.6%) vs 6.7% (6.6%¿6.8%) of the class.;-At 16th postoperative year: 8.5% (7.9%¿9.0%) vs 7.2% (7.1%¿7.3%) of the class.;-At 17th postoperative year: 9.0% (8.4%¿9.7%) vs 7.7% (7.6%¿7.8%) of the class.;-At 18th postoperative year: 9.5% (8.8%¿10.2%) vs 8.2% (8.0%¿8.3%) of the class.;-At 19th postoperative year: 10.3% (9.6%¿11.1%) vs 8.6% (8.5%¿8.8%) of the class.;-At 20th postoperative year: 10.9% (10.0%¿11.8%) vs 9.1% (9.0%¿9.3%) of the class.;-At 21st postoperative year: 11.8% (10.8%¿12.8%) vs 9.6% (9.4%¿9.8%) of the class.;-At 22nd postoperative year: 12.7% (11.5%¿14.0%) vs 10.1% (9.9%¿10.3%) of the class.;-At 23rd postoperative year: 13.4% (12.1%¿15.0%) vs 10.5% (10.3%¿10.8%) of the class.;-At 24th postoperative year: 13.4% (12.1%¿15.0%) vs 11.1% (10.8%¿11.4%) of the class.;;A potential reason for the elevated revision rate for the CoCr variant could be driven by factors not necessarily related to the Femoral Head implant but rather other parts of the surgical procedure (e.g., perioperative environment) or co-implanted devices during THA (e.g., femoral stem, acetabular cup, liner, etc.). This concept is demonstrated by the high rates of revisions due to factors such as loosening (>1.0%), implant dislocation (>1.0%) and infection (>1.0%).;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L1,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L2,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L3,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L4,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L5,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L6,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L7,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L8,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L9,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L10,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L11,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L12,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L13,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L14,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L15,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L16,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +0,71292200,,71292200,,03596010466518,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L17,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 22mm +4,71292204,,71292204,,03596010466525,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L18,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 26mm +0,71292600,,71292600,,03596010466570,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L19,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 26mm +0,71292600,,71292600,,03596010466570,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L20,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 26mm +4,71292604,,71292604,,03596010466587,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L21,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L22,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L23,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L24,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L25,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L26,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L27,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L28,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L29,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L30,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L31,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L32,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L33,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L34,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L35,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L36,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L37,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L38,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L39,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L40,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L41,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L42,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L43,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L44,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L45,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L46,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L47,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L48,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L49,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L50,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L51,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L52,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L53,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L54,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L55,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L56,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L57,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L58,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L59,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L60,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L61,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L62,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L63,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L64,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +0,71292800,,71292800,,03596010466617,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L65,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm -3,71292803,,71292803,,03596010466624,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L66,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm -3,71292803,,71292803,,03596010466624,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L67,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm -3,71292803,,71292803,,03596010466624,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L68,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm -3,71292803,,71292803,,03596010466624,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L69,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm -3,71292803,,71292803,,03596010466624,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L70,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm -3,71292803,,71292803,,03596010466624,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L71,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L72,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L73,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L74,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L75,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L76,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L77,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L78,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L79,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L80,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L81,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L82,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L83,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L84,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L85,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L86,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L87,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L88,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L89,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L90,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L91,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L92,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L93,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L94,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L95,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +4,71292804,,71292804,,03596010466631,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L96,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +8,71292808,,71292808,,03596010466648,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L97,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +8,71292808,,71292808,,03596010466648,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L98,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +8,71292808,,71292808,,03596010466648,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L99,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +8,71292808,,71292808,,03596010466648,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L100,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +8,71292808,,71292808,,03596010466648,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L101,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 28mm +12,71292812,,71292812,,03596010466655,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L102,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 32mm +0,71293200,,71293200,,03596010466679,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L103,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 32mm +0,71293200,,71293200,,03596010466679,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L104,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 32mm +0,71293200,,71293200,,03596010466679,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L105,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 32mm -3,71293203,,71293203,,03596010466686,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L106,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 32mm +4,71293204,,71293204,,03596010466693,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L107,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 32mm +4,71293204,,71293204,,03596010466693,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310383-1-L108,,4/28/2026,2/10/2026,Femoral Heads,Stainless Steel 12/14 Taper Femoral Head 32mm +12,71293212,,71293212,,03596010466716,,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR between 09-May-2002 and 07-Jun-2016 in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, one (1) hip required revision due to unknown reasons. It should be noted that, due to the stratification provided by this Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted. Of these, a hundred and eight (108) hips required revision due to the following reasons: eighteen (18) hips due to fracture, fifty (50) hips due to loosening, fourteen (14) hips due to infection, sixteen (16) hips due to prosthesis dislocation, two (2) hips due to lysis, one (1) hip due to pain, six (6) hips due to wear of the acetabular insert, and one (1) hip due to incorrect sizing. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. Timeframe of Registry Data: Implantations conducted between 09-May-2002 and 07-Jun-2016 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the Stainless Steel Femoral Head presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand one hundred and three (1,103) hips underwent primary THR in which a Stainless Steel 12/14 Taper Femoral Head was implanted in Australia between 09-May-2002 and 07-Jun-2016. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;- At 1st post-operative year: 1.1% (0.6%¿1.9%) vs 1.7% (1.7%¿1.8%) of the class.;- At 2nd post-operative year: 1.2% (0.7%¿2.0%) vs 2.2% (2.2%¿2.2%) of the class.;- At 3rd post-operative year: 1.8% (1.1%¿2.8%) vs 2.5% (2.5%¿2.6%) of the class.;- At 4th post-operative year: 2.3% (1.5%¿3.4%) vs 2.8% (2.8%¿2.9%) of the class.;- At 5th post-operative year: 2.3% (1.5%¿3.4%) vs 3.1% (3.1%¿3.2%) of the class.;- At 6th post-operative year: 2.7% (1.9%¿3.9%) vs 3.4% (3.4%¿3.5%) of the class.;- At 7th post-operative year: 3.0% (2.1%¿4.3%) vs 3.7% (3.7%¿3.8%) of the class.;- At 8th post-operative year: 3.6% (2.6%¿5.0%) vs 4.0% (4.0%¿4.1%) of the class.;- At 9th post-operative year: 4.8% (3.6%¿6.4%) vs 4.4% (4.3%¿4.4%) of the class.;- At 10th post-operative year: 6.0% (4.6%¿7.8%) vs 4.7% (4.7%¿4.8%) of the class.;- At 11th post-operative year: 6.7% (5.2%¿8.6%) vs 5.1% (5.0%¿5.1%) of the class.;- At 12th post-operative year: 8.6% (6.8%¿10.8%) vs 5.5% (5.4%¿5.6%) of the class.;- At 13th post-operative year: 9.7% (7.8%¿12.0%) vs 5.9% (5.8%¿6.0%) of the class.;- At 14th post-operative year: 10.3% (8.3%¿12.7%) vs 6.3% (6.2%¿6.4%) of the class.;- At 15th post-operative year: 12.0% (9.8%¿14.8%) vs 6.8% (6.7%¿6.8%) of the class.;- At 16th post-operative year: 13.0% (10.6%¿16.0%) vs 7.3% (7.2%¿7.4%) of the class.;- At 17th post-operative year: 14.7% (12.0%¿17.9%) vs 7.7% (7.6%¿7.8%) of the class.;- At 18th post-operative year: 16.6% (13.5%¿20.2%) vs 8.2% (8.0%¿8.3%) of the class.;- At 19th post-operative year: 18.0% (14.7%¿21.9%) vs 8.6% (8.5%¿8.8%) of the class.;- At 20th post-operative year: 18.0% (14.7%¿21.9%) vs 9.2% (9.0%¿9.3%) of the class.;- At 21st post-operative year: 18.8% (15.2%¿23.0%) vs 9.7% (9.5%¿9.8%) of the class.;- At 22nd post-operative year: 20.2% (15.9%¿25.5%) vs 10.1% (9.9%¿10.3%) of the class.;By observing the cumulative revision rates above, it can be concluded that there is no statistically significant difference between the Stainless Steel 12/14 Taper Femoral Head and the THR class during Years 1 and 3¿10, as determined by overlapping 95% confidence intervals.;A statistically significant difference is observed at Year 2, where the Stainless Steel 12/14 Taper Femoral Head shows lower revision rates than the THR class, and from Year 11 onward (Years 11¿22), where the Stainless Steel 12/14 Taper Femoral Head shows higher cumulative revision rates than the THR class, as indicated by non overlapping 95% confidence intervals. Regarding this last trend, the low number of Stainless-Steel Femoral Head implants at risk during this period (N=48 at 22 years) likely contributes to these higher rates of revision.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315650-1-L1,,4/28/2026,3/4/2026,REDAPT Acetabular System ,REDAPT Acetabular Cup ,,,,,,K150790,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a REDAPT Acetabular Cup was implanted between 01-Jan-2019 and 31-Dec-2025, one (1) hip required revision due to infection.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and nine (109) hips underwent primary THR in which a REDAPT Acetabular Cup was implanted. Of these, three (3) hips required revision due to the following reasons: one (1) hip due to infection, one (1) due to loosening and one (1) due to prothesis dislocation.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2019 and 31-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one hundred and nine (109) hips underwent primary THR in which a REDAPT Acetabular Cup was implanted in Australia between 01-Jan-2019 and 31-Dec-2025, with only three revisions for infection. Due to the low number of implantations and short follow-up time, the Kaplan-Meier revision rates cannot be accurately calculated. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315650-1-L2,,4/28/2026,3/4/2026,REDAPT Acetabular System ,REDAPT Acetabular Cup ,,,,,,K150790,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a REDAPT Acetabular Cup was implanted between 01-Jan-2019 and 31-Dec-2025, one (1) hip required revision due to loosening.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and nine (109) hips underwent primary THR in which a REDAPT Acetabular Cup was implanted. Of these, three (3) hips required revision due to the following reasons: one (1) hip due to infection, one (1) due to loosening and one (1) due to prothesis dislocation.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2019 and 31-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one hundred and nine (109) hips underwent primary THR in which a REDAPT Acetabular Cup was implanted in Australia between 01-Jan-2019 and 31-Dec-2025, with only three revisions for infection. Due to the low number of implantations and short follow-up time, the Kaplan-Meier revision rates cannot be accurately calculated. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00315650-1-L3,,4/28/2026,3/4/2026,REDAPT Acetabular System ,REDAPT Acetabular Cup ,,,,,,K150790,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), after undergoing primary THR in which a REDAPT Acetabular Cup was implanted between 01-Jan-2019 and 31-Dec-2025, one (1) hip required revision due to prothesis dislocation.","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of one hundred and nine (109) hips underwent primary THR in which a REDAPT Acetabular Cup was implanted. Of these, three (3) hips required revision due to the following reasons: one (1) hip due to infection, one (1) due to loosening and one (1) due to prothesis dislocation.;Timeframe of Registry Data: Implantations conducted between 01-Jan-2019 and 31-Dec-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one hundred and nine (109) hips underwent primary THR in which a REDAPT Acetabular Cup was implanted in Australia between 01-Jan-2019 and 31-Dec-2025, with only three revisions for infection. Due to the low number of implantations and short follow-up time, the Kaplan-Meier revision rates cannot be accurately calculated. ;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00310624-1-L1,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L2,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L3,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L4,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L5,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 0,71302200,,71302200,,03596010194039,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L6,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 4,71302204,,71302204,,03596010194046,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L7,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 22MM + 8,71302208,,71302208,,03596010194053,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L8,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L9,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L10,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L11,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L12,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L13,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L14,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L15,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L16,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L17,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L18,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L19,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L20,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L21,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L22,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L23,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L24,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L25,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L26,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L27,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L28,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L29,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L30,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L31,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L32,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L33,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L34,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L35,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L36,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L37,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L38,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L39,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L40,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L41,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L42,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L43,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L44,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L45,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L46,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L47,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L48,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L49,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L50,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L51,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L52,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L53,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L54,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L55,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L56,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L57,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L58,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L59,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L60,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L61,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L62,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L63,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L64,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L65,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L66,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L67,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L68,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L69,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L70,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L71,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L72,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L73,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L74,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L75,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L76,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L77,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L78,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L79,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L80,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L81,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L82,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L83,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L84,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L85,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L86,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L87,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L88,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L89,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L90,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L91,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L92,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L93,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L94,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L95,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L96,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L97,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L98,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L99,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L100,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L101,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L102,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L103,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L104,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L105,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L106,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L107,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L108,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L109,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 0,71302800,,71302800,,03596010194114,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L110,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L111,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L112,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L113,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L114,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L115,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L116,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L117,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L118,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L119,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L120,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L121,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L122,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L123,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L124,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L125,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L126,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L127,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L128,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L129,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L130,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L131,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L132,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM - 3,71302803,,71302803,,03596010194121,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L133,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L134,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L135,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L136,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L137,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L138,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L139,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L140,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L141,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L142,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L143,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L144,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L145,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L146,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L147,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L148,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L149,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L150,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L151,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L152,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L153,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L154,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L155,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L156,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L157,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L158,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L159,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L160,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L161,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L162,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L163,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 4,71302804,,71302804,,03596010194138,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L164,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L165,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L166,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L167,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L168,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L169,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L170,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L171,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 8,71302808,,71302808,,03596010194145,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00310624-1-L172,,4/28/2026,2/10/2026,Femoral Heads,COBALT CHROME 12/14 TAPER FEMORAL HEAD 28MM + 16,71302816,,71302816,,03596010194169,K963509,,IN,"It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one (1) hip was later revised due to unknown reasons. Based on the stratification used by the AOANJRR, no specific reason for revision can be definitively linked to the individual femoral component reported through this line item. ","Reporting Quarter: 1 (January 1 - March 31, 2026);;Summary of adverse events: It was reported that, in the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of four thousand nine hundred two (4,902) hips underwent primary hip hemiarthroplasty procedures between 17-Aug-2000 and 26-Nov-2025, using CoCr Femoral Heads with TANDEM Bipolar System. From these, one hundred seventy-two (172) hips were later revised due to the following complications: forty eight (48) hips due to infection, forty four (44) hips due to prosthesis dislocation, twenty four (24) hips due to fracture, nineteen (19) hips due to loosening, eighteen (18) hips due to chondrolysis/acetabular erosion, eight (8) hips due to pain, three (3) hips due to lysis, two (2) hips due to tumour, one (1) hip due to incorrect sizing, one (1) hip due to malposition, one (1) hip due to leg length discrepancy, one (1) hip due to implant breakage ¿ head, one (1) hip due to progression of disease, and one (1) hip due to other reasons. It should be noted that, based on the data stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be distinctly matched to the corresponding medical devices involved in each revision case.;;Timeframe of Registry data: Implantations conducted between 17-Aug-2000 and 26-Nov-2025 in Australia.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the Femoral Heads presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of four thousand nine hundred two (4,902) procedures using CoCr Femoral Heads with TANDEM Bipolar System in primary hip hemiarthroplasty have been performed in Australia between 17-Aug-2000 and 26-Nov-2025. ;;The cumulative revision rates for CoCr Femoral Heads used with TANDEM Bipolar System during hemiarthroplasty across 17 years of follow-up were in line with the class device as indicated by the overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 2.5% (2.1%¿3.1%) vs 2.4% (2.2%¿2.6%) of the class.;-At 2nd postoperative year: 3.2% (2.7%¿3.8%) vs 3.0% (2.9%¿3.2%) of the class.;-At 3rd postoperative year: 3.7% (3.1%¿4.4%) vs 3.4% (3.2%¿3.6%) of the class.;-At 4th postoperative year: 4.0% (3.4%¿4.7%) vs 3.8% (3.6%¿4.0%) of the class.;-At 5th postoperative year: 4.5% (3.8%¿5.3%) vs 4.1% (3.8%¿4.3%) of the class.;-At 6th postoperative year: 5.0% (4.2%¿5.9%) vs 4.3% (4.1%¿4.6%) of the class.;-At 7th postoperative year: 5.4% (4.5%¿6.5%) vs 4.6% (4.3%¿4.9%) of the class.;-At 8th postoperative year: 6.0% (4.9%¿7.3%) vs 5.0% (4.7%¿5.4%) of the class.;-At 9th postoperative year: 6.2% (5.1%¿7.7%) vs 5.4% (5.0%¿5.8%) of the class.;-At 10th postoperative year: 7.2% (5.7%¿9.0%) vs 5.8% (5.4%¿6.2%) of the class.;-At 11th postoperative year: 7.6% (5.9%¿9.6%) vs 5.9% (5.5%¿6.4%) of the class.;-At 12th postoperative year: 7.6% (5.9%¿9.6%) vs 6.3% (5.8%¿6.8%) of the class.;-At 13th postoperative year: 7.6% (5.9%¿9.6%) vs 6.5% (6.0%¿7.1%) of the class.;-At 14th postoperative year: 7.6% (5.9%¿9.6%) vs 7.1% (6.5%¿7.8%) of the class.;-At 15th postoperative year: 7.6% (5.9%¿9.6%) vs 7.7% (6.9%¿8.5%) of the class.;-At 16th postoperative year: 8.6% (6.3%¿11.7%) vs 8.4% (7.5%¿9.4%) of the class.;-At 17th postoperative year: 8.6% (6.3%¿11.7%) vs 8.6% (7.7%¿9.7%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary.; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,, ,F1905, ,G07001,B20;B22,C19,D12;D15, ,0;CASE-2026-00316749-1-L1,,4/28/2026,3/4/2026,REDAPT Acetabular System ,REDAPT MODULAR SHELL 52MM,71352352,,71352352,,00885556657812,K182109,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-nine (39) hips underwent primary THR between 27-Nov-2019 and 06-Oct-2025 in which a REDAPT Modular Acetabular Shell was implanted. Of these, one (1) hip required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-nine (39) hips underwent revision THR between 27-Nov-2019 and 06-Oct-2025 in which a REDAPT Modular Acetabular Shell was implanted. Of these, four (4) hips required re-revision due to the following reasons: two (2) hips due to prothesis dislocation, one (1) hip due to loosening and one (1) due to infection.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 27-Nov-2019 and 06-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-nine (39) hips underwent revision THR in which a REDAPT Modular Acetabular Shell was implanted in Australia between 27-Nov-2019 and 06-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.9% (2.6%¿22.6%) vs 7.9% (7.4%¿8.4%) of the class.;? At 2nd post-operative year: 13.0% (4.8%¿32.7%) vs 10.2% (9.6%¿10.7%) of the class.;? At 3rd post-operative year: 13.0% (4.8%¿32.7%) vs 11.6% (11.0%¿12.2%) of the class.;? At 4th post-operative year: 13.0% (4.8%¿32.7%) vs 12.8% (12.2%¿13.4%) of the class.;By observing the cumulative re-revision rates listed above, it can be determined that there is no statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class (Other Revision Hip) for post-operative years 1 through 4, as evidenced by overlapping 95% confidence intervals at each assessed timepoint.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316749-1-L2,,4/28/2026,3/4/2026,REDAPT Acetabular System ,REDAPT MODULAR SHELL 52MM,71352352,,71352352,,00885556657812,K182109,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-nine (39) hips underwent primary THR between 27-Nov-2019 and 06-Oct-2025 in which a REDAPT Modular Acetabular Shell was implanted. Of these, one (1) hip required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-nine (39) hips underwent revision THR between 27-Nov-2019 and 06-Oct-2025 in which a REDAPT Modular Acetabular Shell was implanted. Of these, four (4) hips required re-revision due to the following reasons: two (2) hips due to prothesis dislocation, one (1) hip due to loosening and one (1) due to infection.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 27-Nov-2019 and 06-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-nine (39) hips underwent revision THR in which a REDAPT Modular Acetabular Shell was implanted in Australia between 27-Nov-2019 and 06-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.9% (2.6%¿22.6%) vs 7.9% (7.4%¿8.4%) of the class.;? At 2nd post-operative year: 13.0% (4.8%¿32.7%) vs 10.2% (9.6%¿10.7%) of the class.;? At 3rd post-operative year: 13.0% (4.8%¿32.7%) vs 11.6% (11.0%¿12.2%) of the class.;? At 4th post-operative year: 13.0% (4.8%¿32.7%) vs 12.8% (12.2%¿13.4%) of the class.;By observing the cumulative re-revision rates listed above, it can be determined that there is no statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class (Other Revision Hip) for post-operative years 1 through 4, as evidenced by overlapping 95% confidence intervals at each assessed timepoint.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316749-1-L3,,4/28/2026,3/4/2026,REDAPT Acetabular System ,REDAPT MODULAR SHELL 54MM,71352354,,71352354,,00885556657836,K182109,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-nine (39) hips underwent primary THR between 27-Nov-2019 and 06-Oct-2025 in which a REDAPT Modular Acetabular Shell was implanted. Of these, one (1) hip required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-nine (39) hips underwent revision THR between 27-Nov-2019 and 06-Oct-2025 in which a REDAPT Modular Acetabular Shell was implanted. Of these, four (4) hips required re-revision due to the following reasons: two (2) hips due to prothesis dislocation, one (1) hip due to loosening and one (1) due to infection.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 27-Nov-2019 and 06-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-nine (39) hips underwent revision THR in which a REDAPT Modular Acetabular Shell was implanted in Australia between 27-Nov-2019 and 06-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.9% (2.6%¿22.6%) vs 7.9% (7.4%¿8.4%) of the class.;? At 2nd post-operative year: 13.0% (4.8%¿32.7%) vs 10.2% (9.6%¿10.7%) of the class.;? At 3rd post-operative year: 13.0% (4.8%¿32.7%) vs 11.6% (11.0%¿12.2%) of the class.;? At 4th post-operative year: 13.0% (4.8%¿32.7%) vs 12.8% (12.2%¿13.4%) of the class.;By observing the cumulative re-revision rates listed above, it can be determined that there is no statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class (Other Revision Hip) for post-operative years 1 through 4, as evidenced by overlapping 95% confidence intervals at each assessed timepoint.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00316749-1-L4,,4/28/2026,3/4/2026,REDAPT Acetabular System ,REDAPT MODULAR SHELL 58MM,71352358,,71352358,,00885556657850,K182109,,IN,"It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-nine (39) hips underwent primary THR between 27-Nov-2019 and 06-Oct-2025 in which a REDAPT Modular Acetabular Shell was implanted. Of these, one (1) hip required re-revision due to unknown reasons. Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ","Reporting Quarter: 1 (January 1st to March 31st) 2026;Summary of adverse events: It was reported that, based on the data gathered by the Australia Orthopedic Association National Joint Replacement Registry (AOANJRR), a total of thirty-nine (39) hips underwent revision THR between 27-Nov-2019 and 06-Oct-2025 in which a REDAPT Modular Acetabular Shell was implanted. Of these, four (4) hips required re-revision due to the following reasons: two (2) hips due to prothesis dislocation, one (1) hip due to loosening and one (1) due to infection.;Due to the stratification provided by the Joint Registry, the specific reasons for each revision procedure cannot be directly correlated with the individual part numbers reported. As such, it is not possible to determine which specific part numbers were associated with which specific reasons for revision. ;Timeframe of Registry Data: Implantations conducted between 27-Nov-2019 and 06-Oct-2025 in Australia;Analysis Conducted: Based on the most recent safety and performance evaluation, the REDAPT Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of thirty-nine (39) hips underwent revision THR in which a REDAPT Modular Acetabular Shell was implanted in Australia between 27-Nov-2019 and 06-Oct-2025. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;? At 1st post-operative year: 7.9% (2.6%¿22.6%) vs 7.9% (7.4%¿8.4%) of the class.;? At 2nd post-operative year: 13.0% (4.8%¿32.7%) vs 10.2% (9.6%¿10.7%) of the class.;? At 3rd post-operative year: 13.0% (4.8%¿32.7%) vs 11.6% (11.0%¿12.2%) of the class.;? At 4th post-operative year: 13.0% (4.8%¿32.7%) vs 12.8% (12.2%¿13.4%) of the class.;By observing the cumulative re-revision rates listed above, it can be determined that there is no statistically significant difference between the re-revision rates of the REDAPT Modular Acetabular Shell and the revision THR class (Other Revision Hip) for post-operative years 1 through 4, as evidenced by overlapping 95% confidence intervals at each assessed timepoint.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,,,,,,,F1905,,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY (THA): 1. PRIMARY TOTAL HIP ARTHROPLASTY (THA): - OR3O DUAL MOBILITY XLPE INSERT: A TOTAL OF TWO HUNDRED AND SEVENTY-SIX (276) HIPS UNDERWENT PRIMARY THA BETWEEN 15-JUL-2021 AND 30-JUN-2025, UPON WHICH AN OR3O HIP INSERT WAS PLACED. FROM THESE, ONE (1) HIP PRESENTED MALPOSITION WHICH REQUIRED REVISION SURGERY. - R3 CONSTRAINED LINER: A TOTAL OF THIRTY-FOUR (34) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 1-SEP-1999 TO 20-MAR-2025, USING AN R3 CONSTRAINED LINER. FROM THESE, TWO (2) HIPS WERE LATER REVISED DUE TO IMPLANT BREAKAGE OF THE ACETABULAR INSERT (X1) AND ASEPTIC LOOSENING (X1). - REFLECTION UHMWPE LINER: A TOTAL OF TWO THOUSAND SIX HUNDRED AND SIXTEEN (2,616) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 02-SEP-1999 AND 30-JUN-2009, USING A REFLECTION ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) LINER. FROM THESE, FOUR HUNDRED AND TWENTY NINE (429) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY-NINE (29) HIPS DUE TO FRACTURE, ONE HUNDRED AND FIFTY (150) HIPS DUE TO LOOSENING, FORTY-TWO (42) HIPS DUE TO INFECTION, SEVENTY (70) HIPS DUE TO PROSTHESIS DISLOCATION, SEVENTY-ONE (71) HIPS DUE TO LYSIS, ONE (1) HIP DUE TO PAIN, TWO (2) HIPS DUE TO INSTABILITY, TWO (2) HIPS DUE TO LEG LENGTH DISCREPANCY, ONE (1) HIP DUE TO MALPOSITION, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, ONE (1) HIP DUE TO INCORRECT SIZING, FIFTY (50) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, THREE (3) HIPS DUE TO WEAR ¿ ACETABULUM, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND TWO (2) HIPS DUE TO OTHER CAUSES. - REFLECTION XLPE ACETABULAR LINER: A TOTAL OF THIRTEEN THOUSAND NINE HUNDRED AND SEVENTY-ONE (13,971) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 05-OCT-2020 AND 28-JAN-2025, USING A REFLECTION XLPE LINER. THIS TOTAL INCLUDES REFLECTION XLPE LINER COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JDI AND LPH. OF THE FIVE HUNDRED AND FIFTY-SEVEN (557) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, ONE HUNDRED THREE (103) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 557 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LPH. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO PERIPROSTHETIC FRACTURE, TWO HUNDRED AND FORTY (240) HIPS DUE TO LOOSENING, ONE HUNDRED AND THIRTY-FOUR (134) HIPS DUE TO INFECTION, ONE HUNDRED AND SIXTY-THREE (163) HIPS DUE TO PROSTHESIS DISLOCATION, SIXTY-EIGHT (68) HIPS DUE TO LYSIS, SEVEN (7) HIPS DUE TO INSTABILITY, FIVE (5) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, FORTY-THREE (43) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND ONE (1) HIP DUE TO WEAR ¿ ACETABULUM. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 557 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 103 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 103 CASES. 2. REVISION TOTAL HIP ARTHROPLASTY (THA): - REFLECTION ACETABULAR SHELL: TOTAL OF NINETY-FIVE (95) HIP JOINTS UNDERWENT REVISION THA PROCEDURES USING A REFLECTION ACETABULAR SHELL IN LIEU OF THE PRIMARY COMPONENT BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES REFLECTION ACETABULAR SHELL COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES LPH, MBL AND MEH. FROM THIS COHORT, EIGHTEEN (18) HIPS UNDERWENT A RE-REVISION SURGERY DUE TO SEVERAL CAUSES. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR ALL 18 RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LPH. THE REPORTED REASONS FOR RE-REVISION INCLUDE: SIX (6) HIPS DUE TO PROTHESIS DISLOCATION, FIVE (5) DUE TO INFECTION, AND THE SEVEN (7) REMAINING JOINTS BECAUSE OF THE FOLLOWING CAUSES (ONE PER JOINT): LOOSENING, FRACTURE, STEM IMPLANT BREAKAGE, LYSIS, PAIN, HETEROTOPIC BONE, AND WEAR OF THE ACETABULAR INSERT. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 18 RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 3 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR SHELL COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR RE-REVISION EXCLUSIVELY TO THE SUBSET OF 3 CASES. - REFLECTION MULTI-HOLE ACETABULAR CUP: A TOTAL OF TWENTY-THREE (23) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 20-APR-2004 AND 7-SEP-2013, USING A REFLECTION MULTI-HOLE ACETABULAR CUP. FROM THESE, THREE (3) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO LOOSENING, ONE (1) HIP DUE TO PROSTHETIC DISLOCATION AND ONE (1) HIP DUE TO OTHER UNKNOWN REASONS. ALTOGETHER, A TOTAL QUANTITY OF 535 REVISIONS AND 6 RE-REVISIONS (541 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR)FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION OR RE-REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THE PROCEDURES USING A REFLECTION SHELL AND LINER.

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN THAS. 1. PRIMARY PROCEDURES OR3O DUAL MOBILITY XLPE INSERT: A TOTAL OF A HUNDRED AND NINETY-FIVE (195) HIPS UNDERWENT PRIMARY THA BETWEEN 15-JUL-2021 AND 25-MAR-2025, UPON WHICH AN OR3O HIP INSERT WAS PLACED. FROM THESE, ONE (1) HIP WAS LATER REVISED DUE TO MALPOSITION. R3 CONSTRAINED LINER: A TOTAL OF THIRTY-FOUR (34) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 1-SEP-1999 TO 20-MAR-2025, USING AN R3 CONSTRAINED LINER. FROM THESE, TWO (2) HIPS WERE LATER REVISED DUE TO IMPLANT BREAKAGE OF THE ACETABULAR INSERT (X1) AND ASEPTIC LOOSENING (X1). REFLECTION UHMWPE LINER: A TOTAL OF TWO THOUSAND SIX HUNDRED AND SIXTEEN (2,616) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 02-SEP-1999 AND 30-JUN-2009, USING A REFLECTION ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) LINER. FROM THESE, FOUR HUNDRED AND TWENTY NINE (429) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWENTY-NINE (29) HIPS DUE TO FRACTURE, ONE HUNDRED AND FIFTY (150) HIPS DUE TO LOOSENING, FORTY-TWO (42) HIPS DUE TO INFECTION, SEVENTY (70) HIPS DUE TO PROSTHESIS DISLOCATION, SEVENTY-ONE (71) HIPS DUE TO LYSIS, ONE (1) HIP DUE TO PAIN, TWO (2) HIPS DUE TO INSTABILITY, TWO (2) HIPS DUE TO LEG LENGTH DISCREPANCY, ONE (1) HIP DUE TO MALPOSITION, TWO (2) HIPS DUE TO METAL RELATED PATHOLOGY, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, ONE (1) HIP DUE TO INCORRECT SIZING, FIFTY (50) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, THREE (3) HIPS DUE TO WEAR ¿ ACETABULUM, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND TWO (2) HIPS DUE TO OTHER CAUSES. REFLECTION XLPE ACETABULAR LINER: A TOTAL OF THIRTEEN THOUSAND NINE HUNDRED AND SEVENTY-ONE (13,971) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 05-OCT-2020 AND 28-JAN-2025, USING A REFLECTION XLPE LINER. THIS TOTAL INCLUDES REFLECTION XLPE LINER COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES JDI AND LPH. OF THE FIVE HUNDRED AND FIFTY-SEVEN (557) REVISION SURGERIES REPORTED FOR THESE IMPLANTS, ONE HUNDRED THREE (103) REVISIONS WERE ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR REVISION FOR ALL 557 REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LPH. THE REPORTED REASONS FOR REVISION INCLUDE: ONE HUNDRED AND FORTY-FOUR (144) HIPS DUE TO PERIPROSTHETIC FRACTURE, TWO HUNDRED AND FORTY (240) HIPS DUE TO LOOSENING, ONE HUNDRED AND THIRTY-FOUR (134) HIPS DUE TO INFECTION, ONE HUNDRED AND SIXTY-THREE (163) HIPS DUE TO PROSTHESIS DISLOCATION, SIXTY-EIGHT (68) HIPS DUE TO LYSIS, SEVEN (7) HIPS DUE TO INSTABILITY, FIVE (5) HIPS DUE TO IMPLANT BREAKAGE ¿ STEM, ONE (1) HIP DUE TO IMPLANT BREAKAGE ¿ ACETABULAR INSERT, FORTY-THREE (43) HIPS DUE TO WEAR ¿ ACETABULAR INSERT, TWO (2) HIPS DUE TO IMPLANT BREAKAGE ¿ ACETABULAR, THREE (3) HIPS DUE TO INCORRECT SIZING, ONE (1) HIP DUE TO TUMOUR, ONE (1) HIP DUE TO HETEROTOPIC BONE, AND ONE (1) HIP DUE TO WEAR ¿ ACETABULUM. IN CONSIDERATION OF THE ABOVE, THE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 557 REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 103 REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION XLPE LINER COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR REVISION EXCLUSIVELY TO THE SUBSET OF 103 CASES. 2. REVISION PROCEDURES REFLECTION ACETABULAR SHELL: TOTAL OF NINETY-FIVE (95) HIP JOINTS UNDERWENT REVISION THA PROCEDURES USING A REFLECTION ACETABULAR SHELL IN LIEU OF THE PRIMARY COMPONENT BETWEEN 23-OCT-2000 AND 24-JUL-2015. THIS TOTAL INCLUDES REFLECTION ACETABULAR SHELL COMPONENTS APPROVED FOR USE IN THE UNITED STATES UNDER FDA PRODUCT CODES LPH, MBL AND MEH. FROM THIS COHORT, EIGHTEEN (18) HIPS UNDERWENT A RE-REVISION SURGERY DUE TO SEVERAL CAUSES. THE AOANJRR REPORT PROVIDES THE COMPLETE LIST OF REASONS FOR ALL 18 RE-REVISION CASES BUT DOES NOT DISTINGUISH WHICH REASONS ARE SPECIFICALLY LINKED TO RE-REVISION SURGERIES INVOLVING COMPONENTS APPROVED UNDER FDA PRODUCT CODE LPH. THE REPORTED REASONS FOR RE-REVISION INCLUDE: SIX (6) HIPS DUE TO PROTHESIS DISLOCATION, FIVE (5) DUE TO INFECTION, AND THE SEVEN (7) REMAINING JOINTS BECAUSE OF THE FOLLOWING CAUSES (ONE PER JOINT): LOOSENING, FRACTURE, STEM IMPLANT BREAKAGE, LYSIS, PAIN, HETEROTOPIC BONE, AND WEAR OF THE ACETABULAR INSERT. IN CONSIDERATION OF THE ABOVE, HE ANALYSIS CONDUCTED ON THE AOANJRR REGISTRY REPORT ENCOMPASSES ALL 18 RE-REVISION SURGERIES REPORTED FOR THIS PRODUCT FAMILY. HOWEVER, THE .CSV FILE SUBMITTED UNDER THE REQUIREMENTS OF RWD2300584 INCLUDES ONLY 3 RE-REVISIONS ASSOCIATED WITH HIPS THAT HAD PREVIOUSLY RECEIVED A REFLECTION ACETABULAR SHELL COMPONENT APPROVED UNDER FDA PRODUCT CODE LPH. DUE TO THE STRUCTURE OF AOANJRR REPORT, IT IS NOT POSSIBLE TO ISOLATE OR ATTRIBUTE SPECIFIC STATISTICAL OUTCOMES OR REASONS FOR RE-REVISION EXCLUSIVELY TO THE SUBSET OF 3 CASES. REFLECTION MULTI-HOLE ACETABULAR CUP: A TOTAL OF TWENTY-THREE (23) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 20-APR-2004 AND 7-SEP-2013, USING A REFLECTION MULTI-HOLE ACETABULAR CUP. FROM THESE, THREE (3) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING REASONS: ONE (1) HIP DUE TO LOOSENING, ONE (1) HIP DUE TO PROSTHETIC DISLOCATION AND ONE (1) HIP DUE TO OTHER UNKNOWN REASONS. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION OR RE-REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THESE PROCEDURES. ALTOGETHER, A TOTAL QUANTITY OF 535 REVISIONS AND 6 RE-REVISIONS (541 EVENTS IN TOTAL) HAVE BEEN REPORTED IN THE AOANJRR FOLLOWING THE USE OF THE S+N IMPLANTS REFERENCED ABOVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
541863		PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	LPH	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR	Unknown

Terms

Patient problem · 16

• Aseptic loosening
• Deformity/ Disfigurement
• Erosion
• Extraskeletal ossification
• Insufficient Information
• Joint Dislocation
• Joint Laxity
• Metal Related Pathology
• Necrosis
• Osteolysis
• Pain
• Periprosthetic fracture
• Solid Tumour
• Synovitis
• Unequal Limb Length
• Unspecified Infection

Product problems · 7

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

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission